Archive
Quality Considerations: Redefining Test Systems from Animals to Tissues and Beyond
August 28, 2017The use of non-whole animal test methods transforms the way regulatory requirements are applied in preclinical testing. Recent global regulatory initiatives emphasize the importance of transitioning to human relevant assays and test systems that do not use animals. When these methods are moved from research into the regulated arena, GLP principles must be followed. The GLPs were originally written in the 1970s, when the vast majority of regulated research was performed using animals as the test system. Current innovative, alternative...
In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use
August 17, 2017In 2009, the passing of the Family Smoking Prevention and Tobacco Control Act facilitated the establishment of the FDA Center for Tobacco Products (CTP), and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed ‘modified risk’. On April 4-6, 2016, IIVS convened a workshop conference entitled, In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products, to bring together stakeholders representing regulatory agencies, academia and industry to address the research priorities...
Awards of VITROCELL In Vitro Inhalation Exposure Systems
June 30, 2017The PETA International Science Consortium (PISC) awarded four VITROCELL in vitro exposure systems to researchers from institutions in the UK, US, and Belgium who are leading the development of non-animal methods to test the toxicity of airborne substances. IIVS is grateful to PISC for donating the VITROCELL System for use in its new respiratory toxicology laboratory. The new lab provides non-animal testing services for evaluating potential respiratory hazards associated with novel ingredients and chemistries used in fragrances, personal care products, household and institutional cleaning...
Using In Vitro Assays, the Direct Peptide Reactivity Assay (DPRA), KeratinoSens™ Assay (KS), and Human Cell Line Activation Test (h-CLAT) to Assess Skin Sensitization Potential of Electronic Cigarette Liquids
April 4, 2017Three regulatory accepted in vitro assays were evaluated in a proof-of-concept project to determine skin sensitization potential of electronic cigarette liquids (eliquids). These assays measure molecular initiating events and initial cellular responses prescribed in the OECD Integrated Testing Strategy (ITS) describing key events in the adverse outcome pathway (AOP) leading to skin sensitization....
Assessment of In Vitro COPD Models for Tobacco Regulatory Science: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use
March 30, 2017On 8-10 December 2014, IIVS organised a workshop conference, entitled Assessment of In Vitro COPD Models for Tobacco Regulatory Science, to bring together stakeholders representing regulatory agencies, academia, industry and animal protection, to address the research priorities articulated by the FDA-CTP. Specific topics were covered to assess the status of current Assessment of In Vitro COPD Models for Tobacco Regulatory Science technologies as they are applied to understanding the adverse pulmonary events resulting from tobacco product exposure, and in particular,...
Precision Digital Dispensing of Patterned Picoliter Quantities of Test Material onto Apical Surfaces of Human 3D-Reconstructed Airway Tissues
March 30, 2017There is an increasing need for researchers to understand the dynamic aspects of inhaled tobacco product exposure. Available 3D human reconstructed airway tissues (RHuA) provide researchers with a more physiological platform that offers apical and basal compartments for flexibility in modelling relevant exposures. We have tested the Tecan D300 digital dispenser as potential technical solution to deliver precise amounts of very small vehicle droplets to coat the apical surface of an available RHuA....
Special issue of Applied In Vitro Toxicology: Next Generation Tobacco Products
March 10, 2017Check out the recently released special issue of Applied In Vitro Toxicology: Application of In Vitro Toxicology Approaches for the Evaluation of Next-Generation Nicotine Products. The issue includes several articles by IIVS scientists and other experts. View the issue online....
In Vitro Models Available for Testing of ENDS
February 20, 2017Presented at the National Academies of Sciences, Engineering, and Medicine's (NAS) workshop on electronic nicotine delivery systems (ENDS), e-cigarettes....
The Use of Human 3D Reconstructed Airway Cultures for Tobacco Product Evaluation: Precision Low-Volume Exposures at the Apical Site
January 10, 2017With a mandate to evaluate the dynamics of pulmonary exposure to inhaled materials such as tobacco-based products, researchers are employing complex, human, three-dimensional pulmonary models. Human reconstructed airway (RHuA) tissues present a platform that more closely resembles airways in vivo. Grown at the air–liquid interface (ALI), RHuA tissues offer apical and basal compartments that allow flexibility in modeling physiologically relevant exposures and provide sampling location-specific results. Read the full article....
Webinar: How GLPs Enhance the Quality of Regulated and Non-Regulated Toxicology
October 18, 2016This one-hour webinar, led by IIVS Director of Quality and Compliance, introduces some of the concepts of Good Laboratory Practices (GLPs) designed to promote study and data integrity within an in vitro toxicology framework. Applying these concepts within your own laboratory should aid in production of robust, repeatable studies. View Slides...